What is the Process for Tissue Donation?

When tissue is donated, it goes through a thorough process to ensure quality and safety. The process involves several phases: a referral and initial screening, recovery process, donor eligibility determination, authorization, tissue processing, and release and distribution.

Referral and initial screening – the tissue recovery organization’s initial determination of donor eligibility includes a review of immediate evidence of communicable disease and other health conditions.

Recovery process – includes obtaining donor blood samples that will be used for infectious disease testing, performing a physical assessment of the body, confirming adherence to critical time limitations, and recovery of tissue using technical, standard operating procedures like those used in surgery.

Donor eligibility determination – much like blood donation, the donor’s medical history and behavioral risk information is obtained and assessed; all documents, histories, records, cultures and test results are reviewed by the tissue bank’s quality assurance program, then the tissue bank’s licensed Medical Director will determine the eligibility of the donor. This determination can occur after processing if the tissue type requires time sensitive processing to preserve expected function.

Authorization-

The tissue recovery organization makes the initial determination of donor eligibility based on medical and social criteria and available information (e.g., age, cause of death, immediate evidence of infection, etc.). If the potential donor is ineligible, no contact with a family member is made and the process is terminated.

If the person is eligible and registered as a donor, the legal next of kin is informed of that decision and tissue donation can proceed.

If the person is eligible and not registered as a donor, a trained requestor contacts the person authorized by law to make an anatomical gift to offer the opportunity to donate. If the legally authorized representative provides authorization, the tissue donation proceeds. If no authorization is provided, the process is terminated.

Tissue processing – time-sensitive processing begins within established time limits; tissue is handled in appropriate environmental conditions and by methods validated to prevent contamination and cross-contamination; physical characteristics of the tissue are evaluated and documented; the tissue is cleansed or decontaminated and, if appropriate, it will be sterilized; a tissue preservation method is selected; and tissue is quarantined until final quality control steps are completed, such as cultures and other testing.

Release and distribution – technical staff perform a thorough review of all records related to tissue processing and quality, which is used in conjunction with the donor eligibility determination performed by the Medical Director in making a decision to release tissue for clinical use.

Why Donate Tissue?

1.75 million The number of tissue transplants performed annually in the U.S.

Saving and improving lives through tissue transplantation would not be possible without the tens of thousands of donors and their families who choose to give the gift of tissue.

If you would like to register as a tissue donor, you can sign up here.